---
kind: "section"
citation: "21 C.F.R. § 1100.3"
title: "21"
number: "1100.3"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/1100.3"
---

# §1100.3. Definitions.


For the purposes of this part:

Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:

- (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
- (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
  - (i) Solely controls moisture and/or temperature of a stored tobacco product; or
  - (ii) **Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.** Component or part means any software or assembly of materials intended or reasonably expected:
- (1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or
- (2) **To be used with or for the human consumption of a tobacco product.** Component or part excludes anything that is an accessory of a tobacco product.

  Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.

  Tobacco product, as stated in [section 201(rr)](/cfr/21/201.md?p=rr) of the Federal Food, Drug, and Cosmetic Act in relevant part:

- (1) Means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product); and
- (2) Does not mean an article that is a drug under [section 201(g)(1)](/cfr/21/201.md?p=g-1) of the Federal Food, Drug, and Cosmetic Act; a device under [section 201(h)](/cfr/21/201.md?p=h) of the Federal Food, Drug, and Cosmetic Act; a combination product described in [section 503(g)](/cfr/21/503.md?p=g) of the Federal Food, Drug, and Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and Cosmetic Act if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine.

## Notes

### Amendments

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]

### Authority

Authority: 21 U.S.C. 371, 374, 387a(b), 387e, 387i; Pub. L. 117-103, 136 Stat. 49.

### Source

Source: 81 FR 29102, May 10, 2016, unless otherwise noted.

### Amendments

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]